Compassionate Use (CU) & Medical Need

The application procedure for implementing a programme which provides medicines for use in cases of distress is described in Articles 106-107 of the royal decree dated 14 December 2006.

A request for approval should be made with the Federal Agency for Medications and Medical Products (Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten, FAGG). A favourable recommendation from an appointed EC is required during the submission process. Patients may be included in the program if approved by the Federal Agency for Medications and Medical Products (FAGG). Notification is given to the local EC for the Maria Middelares General Hospital by way of a study coordinator or physician from the appropriate research department.

For more information, please go to the website for the Federal Agency for Medications and Medical Products (FAGG).